(1) Field of the Invention
The present invention relates to a vial to contain a liquid and from which a syringe can be filled, and more particularly to such a vial whereby a needle is not required for filling the syringe.
(2) Description of the Related Art
Traditionally, drugs in liquid form, such as those to be used for subcutaneous injection, are distributed to the user in pre-measured amounts and concentrations in glass or plastic vials having crimped metal seals that secure a rubber septum over the opening of the vial. The sterility or microbial integrity of the liquid contents of the vial is maintained as long as the seal remains in place and the septum is not penetrated by a non-sterile object.
In order to use the medication, a needle is affixed to a syringe, the plunger of the syringe is withdrawn to a volume that is roughly equivalent to the volume of the liquid that is desired to be transferred to the syringe, the needle is used to pierce the septum, the vial is inverted to place the liquid contents in contact with the needle and the septum, the plunger of the syringe is depressed to inject air into the vial—thus creating a positive pressure in the vial—and then the plunger is again withdrawn while keeping the point of the needle submerged in the liquid, to draw the desired volume of liquid into the barrel of the syringe. Withdrawal of this volume of liquid equalizes pressure within the vial. The needle is then withdrawn from the septum, which re-seals, and the desired subcutaneous injection, or other disposition of the liquid, can take place. If it is desired to maintain a sterile transfer of the liquid, as is true for the injection of medications into living subjects, the needle and the syringe are pre-sterilized.
The septum-sealed vial, as described above, has been in use for many years and has many advantages. However, some drawbacks to the use of this type of system remain, and one is the requirement of the use of a needle in filling the syringe. If the needle that is used to penetrate the septum is either damaged, dulled, or contaminated significantly during the syringe loading process, it must be removed from the syringe and replaced with a new sterile needle. This is not only dangerous to the user, but wasteful of needles. Moreover, the necessity of injecting non-sterile air into the vial—often bubbling it directly through the liquid—in order to insure pressure equalization, compromises the sterility or microbial integrity of the liquid that is withdrawn into the syringe, but more importantly, inoculates any liquid that remains in the vial. If the remaining liquid is not used immediately, growth of microbes that were contained in the initial air injection can quickly spoil the remaining drug.
Various efforts have been made to overcome some of the disadvantages of the vial and septum system. In U.S. Pat. No. 5,035,689, for example, Schroeder described a vial of liquid having a luer-loc flange at its opening that could be attached to a syringe (also having a luer-loc fitting) without the use of a needle. Kimber, in U.S. Pat. No. 5,409,125, described a unit dose container that could engage a “luer lock” syringe fitting when a non-resealable cap was removed by breaking a seal. This device also avoided the use of a needle for filling a syringe.
A different approach was described by Niedospial et al. in U.S. Pat. No. 5,817,082, in which a disposable closure assembly/container was provided that included a normal cap and septum vial, but added an integral spike that could be connected with a luer connector on a syringe to penetrate the septum and permit filling of the syringe. In similar fashion, Browne, in U.S. Pat. No. 6,173,852, described a container comprising a closure system having a septum and an integral spike that penetrated the septum upon rotation of the cap. A Luer connector was provided on the cap to permit filling a syringe without the use of a needle.
Containers that were useful for liquid medications were also designed that had easily openable caps. U.S. Pat. No. Des. 282,348 showed a series of plastic vials having breakable seals, and U.S. Pat. No. 3,356,244 to Witchell, showed a similar feature for a single container. Likewise, U.S. Pat. No. 3,993,223 to Welker et al. described a sealed dispensing container for liquid medicaments having a breakable seal. The container could be flattened by manual force, thereby expelling the contents for use. None of these, however, appeared to be useful for filling a syringe.
In U.S. Pat. No. 4,207,990, Weiler, et al. described a hermetically sealed container having plural access ports, one of which was a twist-off cap, which could be removed to admit a draining spike, the other being a severable dome that could be removed to provide a larger opening. Weiler et al., described another dispensing containing having removable closures in U.S. Pat. No. 4,298,045. There, the dispensing container had a plurality of access apertures of controlled internal and/or external dimensions that were sealed by means of removable closures.
Klauke et al., in U.S. Pat. No. 5,908,124, describe a blow-molded collapsible plastic squeeze tube that is sealed with a twist-off tab. A hermetically sealed container having a dispensing nozzle that is opened with a twist-off tab is described by Weiler in U.S. Pat. No. 6,626,308. This device could also be manufactured by blow-molding.
Despite the many innovations that have been made in the present area, several problems still remain. It would be useful to provide a vial or container that could contain and dispense a sterile liquid into a syringe without the use of a needle. It would be even more useful if this device could be made simply, quickly and inexpensively. Moreover, it would be yet more useful if such a device could be made to be unitary and disposable. It would be yet more useful if the device could maintain the sterility of the liquid during dispensing into a syringe and to avoid the pre-injection of non-sterile air that is presently required for pressure equalization.